MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X71/75; PROSTHESIS, KNEE

Catalog Number 183442

Device Problem Material Erosion (1214)

Patient Problem Joint Laxity (4526)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient began to experience instability and underwent revision surgery due to wear of the articular surface.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: unknown tibial component: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: VNGD CR TIB BRG 12X71/75
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19174150
• MDR Text Key: 340944183
• Report Number: 0001825034-2024-01067
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304271142
• UDI-Public: (01)00880304271142(17)200528(10)199330
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 183442
• Device Lot Number: 199330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose